MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Unstable (1667); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the manufacturer's representative (rep) called to report an issue with charging patient's ins, the wireless recharger (wr) would connect then lose coupling within short period of time.Pt presented to er yesterday with symptoms that were determined to be due to patient's device was depleted.As rep did troubleshooting he noticed that ins appears to be tilted deeper on the bottom end of the ins.Rep reported that pt had a fall about 15 days ago in which rep had checked the device and there were no impedance issues at that time.Rep is unsure if the current location of ins is related to fall.Rep indicated recharging coupling is listed as 2 bars, recharge history shows that device has been charged since mar 18-apr 4th, 2022.Mar 27, 2022 pt got to 100% but after that it fluctuates between 25-50% and on apr 4 battery was at 25%.Ts reviewed optimal location of wr over the ins and suggested trying that to see if coupling improves for patient considering the depth issue on the lower ins end.Rep is going back to see pt today.Additional information was received from the manufacturer's representative.It was reported the ins has dropped in the pocket and connection with the recharger has been lost.The patient is schedule to have surgery to reposition the ins.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported that rep recommended caller call patient services (ps) for assistance with poor coupling during charging with wireless recharger that wireless recharger (wr) had been fully charged yesterday and then today had just shut off.Caller said pt doesn't use charging drape bc it makes things worse.Pt was in hospital for parkinson's disease related reasons, caller confirmed not device related.During call caller started charging session and wr connected with implant immediately, then connected with wireless recharging app immediately with good coupling, dbs therapy was on and implant battery showed 50%.Caller said they were very happy with this and didn't want to troubleshoot further and just wanted implant to charge up.Caller said about 12 weeks ago it had been discovered that the implant had dislodges so about 2 weeks ago the patient 's surgeon had done a revision surgery on the implant where they brought the implant closer to the skin surface in hopes that the implant would charge easier.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14052862
• MDR Text Key: 288871761
• Report Number: 3004209178-2022-04426
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 05/31/2022
• Date Device Manufactured: 08/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 129 KG